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A randomised phase II study of cytotoxic chemotherapy or cytotoxic chemotherapy combined with celecoxib or trastuzumab as primary chemotherapy for patients with high risk localised breast cancer not amenable to breast conserving therapy

A randomised phase II study of cytotoxic chemotherapy or cytotoxic chemotherapy combined with celecoxib or trastuzumab as primary chemotherapy for patients with high risk localised breast cancer not amenable to breast conserving therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10059974
Enrollment
340
Registered
2007-02-08
Start date
2003-10-14
Completion date
Unknown
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localised breast cancer not amenable to breast conserving therapy Cancer Breast cancer

Interventions

Control arm: Cytotoxic chemotherapy consisting of Epirubicin 75 mg/sqm and cyclophosphamide 750 g/sqm every three weeks for four cycles, followed by docetaxel 100 mg/sqm every three we

Sponsors

Remagus (France)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pathologically proven T1c-T4, N0-N1, M0 invasive breast cancer (Tumour, Nodes, Metastasis [TNM] classification) 2. No prior therapy 3. Age 18 to 65 years 4. Available frozen tumour tissue 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Male patient 2. Prior therapy for breast cancer 3. Contraindication to study drug(s) 4. Stage IV breast cancer

Design outcomes

Primary

MeasureTime frame
Pathological response rate—

Secondary

MeasureTime frame
1. Clinical response rate 2. Safety—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026